Articulating apparatus with shipping wedge

ABSTRACT

According to an aspect of the present disclosure, an endoscopic surgical device is provided. The surgical device includes a handle assembly including a drive mechanism actuatable by a trigger; and an endoscopic assembly including a proximal end portion extending from the handle assembly; a distal end portion pivotably connected to the proximal end portion of the endoscopic assembly; and a rotatable inner actuation shaft extending from the handle assembly and into the distal end portion of the endoscopic assembly, the inner actuation shaft including a flexible portion extending across the pivot connection. The surgical device includes an end effector selectively connectable to the distal end portion of the endoscopic assembly and to a distal portion of the rotatable inner actuation shaft. The surgical device includes a shipping wedge to support an end effector.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part application claiming thebenefit of and priority to U.S. patent application Ser. No. 13/930,770,filed Jun. 28, 2013, the entire contents of which are incorporatedherein by reference.

TECHNICAL FIELD

The present disclosure relates to surgical apparatus, devices and/orsystems for performing endoscopic surgical procedures and methods of usethereof. More specifically, the present disclosure relates to surgicalapparatus, devices and/or systems for performing endoscopic surgicalprocedures which includes an articulating endoscopic portion.

BACKGROUND

During laparoscopic or endoscopic surgical procedures, access to asurgical site is achieved through a small incision or through a narrowcannula inserted through a small entrance wound in a patient. Because oflimited area to access the surgical site, many endoscopic surgicaldevices include mechanisms for articulating the tool assembly of thedevice. Typically, the articulating mechanism is controlled by anactuator which has to be manipulated by a surgeon to properly orient thetool assembly in relation to tissue to be treated.

Accordingly, a need exists for endoscopic surgical devices which includefeatures which indicate to the surgeon whether the endoscopic portion ofthe surgical device, when in the surgical site, is in a non-articulatedor articulated orientation.

SUMMARY

The present disclosure relates to surgical apparatus, devices and/orsystems for performing endoscopic surgical procedures which includes anarticulating endoscopic portion.

According to an aspect of the present disclosure, an endoscopic surgicaldevice is provided. The surgical device includes a handle assemblyincluding a handle housing and a trigger operatively connected to thehandle housing, and a drive mechanism actuatable by the trigger; and anendoscopic assembly including a proximal end portion extending from thehandle assembly; a distal end portion pivotably connected to theproximal end portion of the endoscopic assembly at a pivot point; and arotatable inner actuation shaft extending from the handle assembly andinto the distal end portion of the endoscopic assembly, the inneractuation shaft including a flexible portion extending across the pivotpoint, the inner actuation shaft being connected to the drive mechanismof the handle assembly such that an actuation of the trigger results ina rotation of the inner actuation shaft.

The surgical device further includes an end effector selectivelyconnectable to the distal end portion of the endoscopic assembly and toa distal portion of the rotatable inner actuation shaft. The endeffector includes an outer tube having a helical thread along an innersurface thereof; a splined inner tube rotatably supported in the outertube, wherein the splined inner tube is defined by a pair of opposedlongitudinally extending tines and a pair of opposed longitudinallyextending channels, a proximal end of the splined inner tube beingconfigured for non-rotatable selective connection to a distal end of therotatable inner actuation shaft when the end effector is connected tothe distal end portion of the endoscopic assembly; and a plurality ofsurgical anchors loaded in the inner tube of the end effector, whereineach anchor includes a threaded body portion, and a head portiondefining a pair of opposed radially outer threads and a pair of opposedradial recesses, wherein the pair of radial recess of each head portionreceive respective tines of the inner tube and wherein the pair ofopposed radially outer threads of each head portion project from thepair of opposed longitudinally extending channels of the inner tube andengage the inner helical thread of the outer tube.

The endoscopic assembly may include a support tube assembly having aproximal support tube portion extending from the handle assembly, and adistal support tube portion pivotally connected to proximal support tubeportion thereby defining an articulation joint therebetween.

The endoscopic assembly may include an articulation tube slidablysupported in the support tube assembly, a proximal end of thearticulation tube being connected to an articulation actuator supportedon the handle assembly, and a distal end of the articulation tube beingpivotably connected to an articulation link that is also pivotablyconnected to the distal support tube portion of the support tubeassembly.

The inner actuation shaft may be is rotatably supported in thearticulation tube. The inner actuation shaft may include a proximalshaft portion operatively connected to the drive mechanism, a distalshaft portion non-rotatably connected to a distal end of the proximalshaft portion, and a coupling member non-rotatably connected to a distalend of the distal shaft portion.

The distal shaft portion of the inner actuation shaft may be theflexible portion.

The flexible portion of the inner actuation shaft may be relatively moreflexible than the proximal shaft portion of the inner actuation shaft.

In use, an actuation of the trigger may result in a rotation of theinner actuation shaft of the endoscopic assembly.

The drive mechanism may transmit the actuation of the trigger intorotation of the inner actuation shaft of the endoscopic assembly.

The endoscopic assembly may include an inner articulation tube assemblyhaving the articulation tube defining a proximal end and a distal end,the proximal end of the articulation tube being operatively connected tothe articulation actuator. The articulation link may have a proximal endpivotally connected to the distal end of the articulation tube.

The handle assembly may include an articulation knob rotatably supportedthereon. The articulation knob may be the articulation actuator. Thearticulation knob may define an inner helical thread, the proximal endof the articulation tube may be operatively connected to thearticulation tube such that rotation of the articulation knob causes thearticulation tube to axially translate.

In use, axial translation of the articulation tube may cause the distalsupport tube portion of the support tube assembly to pivot about thepivot point.

The endoscopic assembly may include a connection nut fixedly secured tothe proximal end of the articulation tube. The connection nut may definean outer helical thread and may meshingly engage the inner helicalthread of the articulation knob.

The endoscopic assembly may support a ball detent in the distal supporttube portion of the support tube assembly. The ball detent may have aprojected position wherein the ball detent partially projects radiallyoutward from the distal support tube portion of the support tubeassembly. The ball detent may have a retracted position wherein the balldetent does not project radially outward from the distal support tubeportion of the support tube assembly as far as when in the projectedposition.

The ball detent may ride along an outer surface of the coupling memberof the inner actuation shaft of the endoscopic assembly.

The inner actuation shaft may be axially translatable between a proximalposition wherein the ball detent is in the retracted position and adistal position wherein the coupling member of the inner actuation shaftholds the ball detent in the projected position.

In use, when the end effector is connected to the distal end portion ofthe endoscopic assembly, and when the ball detent is in the projectedposition, the ball detent may engage a recess in the end effector tosecure the end effector to the distal end portion of the endoscopicassembly.

The inner actuation shaft may be axially translatable within thearticulation tube.

A proximal end of the proximal shaft portion of the inner actuationshaft may support a pair of axially spaced apart radial flanges.

The handle assembly may include a slider supported thereon. A stem ofthe slider may extend between the pair of axially spaced apart radialflanges supported on the inner actuation shaft.

The slider may be movable between a proximal position and a distalposition. In use, movement of the slider between the proximal positionand the distal position may result in movement of the inner actuationshaft between a respective proximal position and a distal position.

The slider may be in the proximal position, the end effector isconnectable to the to the distal end portion of the endoscopic assembly.In use, when the slider is in the distal position, the end effector maybe secured to the to the distal end portion of the endoscopic assembly.

The endoscopic assembly may support a ball detent in the distal supporttube portion of the support tube assembly. The ball detent may have aprojected position wherein the ball detent partially projects radiallyoutward from the distal support tube portion of the support tubeassembly. The ball detent may have a retracted position wherein the balldetent does not project radially outward from the distal support tubeportion of the support tube assembly as far as when in the projectedposition.

The ball detent may ride along an outer surface of the coupling memberof the inner actuation shaft of the endoscopic assembly.

The ball detent may be in the retracted position when the inneractuation shaft is in the proximal position. The ball detent may be inthe projected position when the inner actuation shaft is in the distalposition.

In use, when the end effector is connected to the distal end portion ofthe endoscopic assembly, and when the ball detent is in the projectedposition, the ball detent may engage a recess in the end effector tosecure the end effector to the distal end portion of the endoscopicassembly.

The handle assembly may include a button supported thereon. The buttonmay include a first position wherein the button blocks movement of theslider, and a second position wherein the button permits movement of theslider.

The button may include a wall extending therefrom. In use, when thebutton is in the first position, the trigger may be actuatable and theslider may be blocked from moving to the proximal position; and when thebutton is in the second position, the wall of the button may block theactuation of the trigger and the slider may be free to move to theproximal position.

The handle assembly may include a biasing member tending to maintain thebutton in one of the first portion and the second position thereon.

The button may include a wall extending therefrom. In use, when thebutton is in the first position, the trigger is actuatable; and when thebutton is in the second position, the wall of the button blocksactuation of the trigger.

The distal end portion of the endoscopic assembly may be pivotable whenthe button is in the second position.

The coupling member of the inner actuation shaft may have a non-circulartransverse cross-sectional profile, and wherein the proximal end of thesplined inner tube of the end effector may have a splined inner tuberotatably supported in the outer tube. The splined inner tube may bedefined by a pair of opposed longitudinally extending tines and a pairof opposed longitudinally extending channels. A proximal end of thesplined inner tube may have a transverse cross-sectional profile thatcomplements the non-circular transverse cross-sectional profile of thecoupling member.

The handle assembly may include an audible/tactile feedback systemassociated with the trigger. The audible/tactile feedback system mayproduce at least one of an audible feedback and a tactile feedback whenthe trigger is in one of a locked out position for loading and unloadingan end effector to the endoscopic assembly, when the trigger has beenfully actuated, and when the trigger returns to a home position.

The distal end portion of the endoscopic assembly may be articulatablebetween a non-articulated orientation and a plurality of articulatedorientations relative to the proximal end portion thereof.

According to another aspect of the present disclosure, an end effectorfor selective connection to a rotatable drive shaft of a surgical handleassembly is provided. The end effector includes an outer tube having ahelical thread along an inner surface thereof; a splined inner tuberotatably supported in the outer tube, wherein the splined inner tube isdefined by a pair of opposed longitudinally extending tines and a pairof opposed longitudinally extending channels, a proximal end of thesplined inner tube being configured for non-rotatable selectiveconnection to a distal end of the rotatable drive shaft of the surgicalhandle assembly when the end effector is connected thereto; and aplurality of surgical anchors loaded in the inner tube.

Each anchor includes a threaded body portion; and a head portiondefining a pair of opposed radially outer threads and a pair of opposedradial recesses, wherein the pair of radial recess of each head portionreceive respective tines of the inner tube and wherein the pair ofopposed radially outer threads of each head portion project from thepair of opposed longitudinally extending channels of the inner tube andengage the inner helical thread of the outer tube.

The proximal end of the inner tube may have a non-circular transversecross-sectional profile.

The helical thread of the outer tube may be defined by a helical coil.

The inner tube may be fixed against longitudinal displacement relativeto the outer tube.

Each surgical anchor may be formed from a bioabsorbable material.

According to still a further aspect of the present disclosure, anendoscopic surgical device configured to fire a surgical anchor intotarget tissue is provided. The surgical device includes a handleassembly including a handle housing; a trigger operatively connected tothe handle housing, the trigger including at least a fully un-actuatedposition; a drive mechanism actuatable by the trigger; and a timingsystem associating the trigger with the drive mechanism.

The surgical device further includes an endoscopic assembly including aproximal end portion extending from the handle assembly; a distal endportion configured to support an end effector; and a rotatable inneractuation shaft extending from the handle assembly and into the distalend portion of the endoscopic assembly, the inner actuation shaft beingconnected to the drive mechanism of the handle assembly such that anactuation of the trigger results in a rotation of the inner actuationshaft to fire a surgical anchor of the surgical device.

In use, the timing system maintains a timing of an actuation stroke ofthe trigger with an actuation of the drive mechanism to fire a singlesurgical anchor upon a single stroke of the trigger from the fullyun-actuated position, to a fully actuated position, to the fullyun-actuated position.

The timing system may include a raceway formed in a surface of thetrigger, the raceway defining a plurality of steps along a lengththereof; and a deflectable arm having a first end disposed within theraceway and operatively associated with the steps thereof, and a secondend connected to the handle housing.

The distal end of the deflectable arm may ride through the raceway whenthe trigger is actuated. The distal end of the deflectable arm may ridethrough the raceway in a single direction during a complete stroke ofthe trigger.

The steps of the raceway may block movement of the distal end of thedeflectable arm, in a reverse direction, through the raceway, when thetrigger is partially actuated.

The raceway may define a home position for the distal end of thedeflectable arm when the trigger is in the fully un-actuated position.

The handle assembly may include a button supported thereon. The buttonmay include a first position wherein the button permits actuation of thetrigger, and wherein the bottom may include a second position whereinthe button blocks actuation of the trigger.

The button may include a wall extending therefrom. In use, when thebutton is in the second position the wall of the button may blockactuation of the trigger.

The trigger may define a notch formed therein. In use, the wall of thebutton may enter the notch of the trigger when the trigger is in thefully un-actuated position and when the button is in the secondposition.

The timing system may include a raceway formed in a surface of thetrigger, the raceway defining a plurality of steps along a lengththereof; and a deflectable arm having a first end disposed within theraceway and operatively associated with the steps thereof, and a secondend connected to the handle housing.

The distal end of the deflectable arm may ride through the raceway whenthe trigger is actuated.

The distal end of the deflectable arm may ride through the raceway in asingle direction during a complete stroke of the trigger.

The steps of the raceway may block movement of the distal end of thedeflectable arm, in a reverse direction, through the raceway, when thetrigger is partially actuated and then un-actuated.

The raceway may define a home position for the distal end of thedeflectable arm when the trigger is in the fully un-actuated position.

The endoscopic assembly may include a support tube assembly having aproximal support tube portion extending from the handle assembly, and adistal support tube portion configured to removably receive the endeffector. The inner actuation shaft may be rotatably supported in thesupport tube, the inner actuation shaft including a proximal portionoperatively connected to the drive mechanism, and a distal portionnon-rotatably supporting a coupling member.

In use, an actuation of the trigger may result in an actuation of thedrive mechanism to rotate the inner actuation shaft of the endoscopicassembly.

The endoscopic assembly may support a ball detent in the distal supporttube portion of the support tube assembly. The ball detent may have aprojected position wherein the ball detent partially projects radiallyoutward from the distal support tube portion of the support tubeassembly. The ball detent may have a retracted position wherein the balldetent does not project radially outward from the distal support tubeportion of the support tube assembly as far as when in the projectedposition.

The ball detent may ride along an outer surface of the coupling memberof the inner actuation shaft of the endoscopic assembly.

The inner actuation shaft may be axially translatable between a proximalposition wherein the ball detent is in the retracted position and adistal position wherein the coupling member of the inner actuation shaftholds the ball detent in the projected position.

In use, the inner actuation shaft may be axially translatable only whenthe trigger is in the fully un-actuated position.

In use, when the end effector is connected to the distal end portion ofthe endoscopic assembly, and when the ball detent is in the projectedposition, the ball detent may engage a recess in the end effector tosecure the end effector to the distal end portion of the endoscopicassembly.

According to yet another aspect of the present disclosure, an endoscopicsurgical device includes an elongate body portion and an end effectorreleasably supported adjacent a distal end of the elongate body portion.

The elongate body portion includes an outer tube and an inner actuationshaft. The inner actuation shaft is movably positioned within the outertube and repositionable between a retracted position and an advancedposition. The inner actuation shaft includes an engagement member thatis concealed within the outer tube in the retracted position and exposedfrom the outer tube in the advanced position.

The elongate body portion may include a proximal portion and a distalportion, the distal portion pivotably connected to the proximal portionat a pivot point.

The end effector includes an engagement member and a plurality ofsurgical anchors. The engagement member of the end effector correspondsto the engagement member of the inner actuation shaft to facilitatereleasable connection of the end effector to the elongate body portion.

In use, the end effector is releasable from the elongate body portionwhen the inner actuation shaft is positioned in the advanced positionand secured to the elongate body portion when the inner actuation shaftis positioned in the refracted position.

The engagement structure of the inner actuation shaft may be located ata distal end of the actuation shaft, and the engagement member of theend effector may be located at a proximal end of the end effector.

The engagement member of the inner actuation shaft may include a recessand the engagement member of the end effector may include a protrusionconfigured and dimensioned for positioning within the recess.

In use, the inner actuation shaft is rotatable within outer tube androtation of the inner actuation shaft is transmitted to the end effectorvia connection of the corresponding engagement members of the inneractuation shaft and the end effector.

The end effector may include an outer tube and an inner tube, the innertube positioned within the outer tube. The inner tube of the endeffector may include a pair of opposed longitudinally extending tinesand may define a pair of opposed longitudinally extending channels.

In use, the inner tube of the end effector may be rotatably supportedwithin the outer tube.

Each anchor may include a threaded body portion and a head portion. Thehead portion may define a pair of opposed radially outer threads and apair of opposed radial recesses. The pair of radial recesses of eachhead portion may receive the pair of tines of the inner tube of the endeffector. The outer tube of the end effector may include a helicalthread along an inner surface thereof. The outer threads of the headportion of each anchor may project from the longitudinally extendingchannels defined by the inner tube of the end effector, and may engagethe helical thread of the outer tube of the end effector.

The endoscopic surgical device may include a handle assembly supportedadjacent a proximal end of the elongate body portion. The handleassembly may include a handle housing, a trigger operatively connectedto the handle housing, and a drive mechanism actuatable by the trigger.

In use, the drive mechanism is connected to the inner actuation shaftsuch that actuation of the trigger results in rotation of the inneractuation shaft.

According to still another aspect of the present disclosure, a method ofperforming a surgical procedure with an endoscopic surgical device isprovided. The method includes advancing an inner actuation shaft of thesurgical device distally to expose a first engagement member formed onthe inner actuation shaft from an outer tube of an elongate bodyportion, securing an end effector to the inner actuation shaft byconnecting the first engagement member to a second engagement memberformed on a proximal end of the end effector, retracting the inneractuation shaft such that the first and second engagement members areconcealed within the outer tube of the elongate body portion, insertingthe end effector into an opening in tissue, and performing a surgicaltask with the end effector.

Securing the end effector to the inner actuation shaft may includeinserting a pin that extends from the second engagement member within arecess defined by the first engagement member.

Advancing the inner actuation shaft may include moving a slide membersupported on a handle assembly of the surgical device in a distaldirection.

Retracting the inner actuation shaft may include moving the slide membersupported on the handle assembly of the surgical device in a proximaldirection.

The method may involve articulating the end effector about a pivot pointvia rotation of an articulation knob rotatably supported on a handleassembly of the surgical device.

Performing the surgical task may include deploying a surgical anchorfrom the end effector, and securing the surgical anchor to tissue.

According to one aspect of the present disclosure, a shipping wedge foran end effector of an endoscopic surgical device is provided. Theshipping wedge includes an elongate body and an angled body that extendsfrom the elongate body at an acute angle relative to the elongate body.The elongate body is configured and dimensioned to receive an elongatebody portion of an endoscopic surgical device and includes a first pairof opposed sidewalls that define a first channel. The first channelextends longitudinally through the elongate body. The angled bodyincludes a second pair of opposed sidewalls that define a second channelconfigured and dimensioned to support an end effector for connection tothe elongate body portion of the endoscopic surgical device.

At least one of the first and second channels may be U-shaped.

The shipping wedge may include an alignment rib that extends from thefirst pair of sidewalls of elongate body. The alignment rib may bepositioned adjacent to the angled body. The alignment rib may define apassage that extends through the alignment rib.

The angled body may include a protuberance that extends from an innersurface of the angled body.

The shipping wedge may include alignment flanges that extend from atleast one of the first and second pairs of sidewalls.

In use, the angled body may prevent the end effector from moving whenthe end effector is supported within the second channel and positionedin axial alignment with the channel.

In use, the first channel may enable the end effector to move throughthe first channel when the end effector is positioned in axial alignmentwith the first channel.

According to yet another aspect of the present disclosure, a method ofremoving an end effector for use with an endoscopic surgical device froma shipping wedge is provided. The method involves securing an endeffector to a shipping wedge, positioning an elongate body portion ofthe endoscopic surgical device within the shipping wedge, advancing theelongate body portion into engagement with the end effector, pivotingthe end effector within the shipping wedge relative to the elongate bodyportion, securing the end effector to the elongate body portion, andremoving the end effector and the elongate body portion from theshipping wedge.

The method may include aligning a distal end of the elongate bodyportion with a proximal end of the end effector. Aligning the elongatebody portion may include abutting the elongate body portion intoengagement with an alignment rib that extends from the shipping wedge.

Removing the end effector and the elongate body portion may includepassing the end effector beneath the alignment rib.

Securing the end effector to the shipping wedge may include securing theend effector to a protuberance that extends from the shipping wedge toprevent the end effector from rotating.

Securing the end effector to the elongate body portion may includedrawing the end effector into engagement with the elongate body portion.

Further details and aspects of exemplary embodiments of the presentinvention are described in more detail below with reference to theappended figures.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure are described herein withreference to the accompanying drawings, wherein:

FIG. 1 is a perspective view of a surgical anchor for use in anendoscopic surgical device in accordance with the present disclosure;

FIG. 2 is a side, elevational view of the surgical anchor of FIG. 1;

FIG. 3 is a distal, end view of the surgical anchor of FIGS. 1 and 2;

FIG. 4 is a side, elevational view, partially broken away, of thesurgical anchor of FIGS. 1-3;

FIG. 5 is an endoscopic surgical device according to an aspect of thepresent disclosure;

FIG. 6 is a perspective view, with parts separated, of the endoscopicsurgical device of FIG. 5;

FIG. 7 is an enlarged view of the indicated area of detail of FIG. 6;

FIG. 8 is a rear perspective view, with a first housing half-sectionremoved therefrom, of a handle assembly of the endoscopic surgicaldevice of FIG. 5;

FIG. 9 is a front perspective view, with a second housing half-sectionremoved therefrom, of a handle assembly of the endoscopic surgicaldevice of FIG. 5;

FIG. 10 is a rear perspective view, with a second housing half-sectionand trigger removed therefrom, of the handle assembly of the endoscopicsurgical device of FIG. 5;

FIG. 11 is a rear perspective view, with parts separated, and with asecond housing half-section removed therefrom, of the handle assembly ofthe endoscopic surgical device of FIG. 5;

FIG. 12 is a perspective view of a pinion gear of the handle assembly ofFIGS. 8-11;

FIG. 13 is a perspective view of a button and slider of the handleassembly of FIGS. 8-11;

FIG. 14 is a perspective view of a bevel gear of the handle assembly ofFIGS. 8-11;

FIG. 15 is a front perspective view, with parts separated, of anendoscopic assembly of the endoscopic surgical device of FIG. 5;

FIG. 16 is an enlarged view of the indicated area of detail of FIG. 15;

FIG. 17 is a rear perspective view of the endoscopic surgical device ofFIG. 5;

FIG. 18 is an enlarged view of the indicated area of detail of FIG. 17;

FIG. 19 is a perspective view of the distal end of the endoscopicsurgical device of FIG. 5 with an end effector shown separatedtherefrom;

FIG. 20 is a rear perspective view of the end effector of FIG. 19;

FIG. 21 is a rear perspective view of the end effector of FIG. 20, withan outer tube removed therefrom;

FIG. 22 is a perspective view of the end effector of FIGS. 20 and 21,with an outer tube separated therefrom;

FIG. 23 is a perspective view of the end effector of FIGS. 20-22, withan outer tube removed therefrom and with parts partially separated;

FIG. 24 is a perspective view of an inner tube of the end effector ofFIGS. 20-23, with a plurality of anchors of FIGS. 1-4 shown separatedtherefrom;

FIG. 25 is a cross-sectional view, as taken along 25-25 of FIG. 22;

FIG. 26 is a cross-sectional view, as taken along 26-26 of FIG. 22;

FIG. 27 is a cross-sectional view, as taken along 27-27 of FIG. 22;

FIG. 28 is a perspective view of the end effector of FIGS. 20-27 with ashipping wedge shown attached thereto;

FIG. 29 is a cross-sectional view as taken through 29-29 of FIG. 28;

FIG. 30 is a cross-sectional view as taken through 30-30 of FIG. 29;

FIG. 31 is a longitudinal, cross-sectional, elevational view of theendoscopic surgical device of FIG. 5;

FIG. 32 is an enlarged view of the indicated area of detail of FIG. 31;

FIG. 33 is an enlarged view of the indicated area of detail of FIG. 31;

FIG. 34 is a cross-sectional view as taken though 34-34 of FIG. 31;

FIG. 35 is an enlarged view of the indicated area of detail of FIG. 34;

FIG. 36 is an enlarged view of the indicated area of detail of FIG. 34;

FIG. 37 is an enlarged view of the indicated area of detail of FIG. 36;

FIG. 38 is a cross-sectional view as taken though 34-34 of FIG. 33;

FIG. 39 is a cross-sectional view as taken though 34-34 of FIG. 33;

FIG. 40 is a cross-sectional view as taken though 34-34 of FIG. 33;

FIG. 41 is a cross-sectional view as taken though 34-34 of FIG. 33;

FIG. 42 is an enlarged elevational view of the handle assembly shown inFIGS. 9 and 10, illustrating an operation of the slider;

FIG. 43 is a longitudinal, cross-sectional view the end effector and theendoscopic assembly of the endoscopic surgical device of FIG. 5,illustrating a first step in the decoupling thereof;

FIG. 44 is a longitudinal, cross-sectional view the end effector and theendoscopic assembly of the endoscopic surgical device of FIG. 5,illustrating a second step in the decoupling thereof;

FIG. 45 is a longitudinal, cross-sectional view an articulation knob ofthe handle assembly of FIGS. 5-11, illustrating a rotation thereof;

FIG. 46 is a longitudinal, cross-sectional view of a distal end of theendoscopic surgical device illustrating an articulation of the endeffector relative to the endoscopic assembly due to a rotation of thearticulation knob;

FIG. 47 is an enlarged elevational view of the handle assembly shown inFIGS. 9 and 10, illustrating an operation of an audible/tactile feedbackmember of the handle assembly, shown in an position following an initialactuation of a trigger;

FIG. 48 is an enlarged elevational view of the handle assembly shown inFIGS. 9 and 10, illustrating an operation of the audible/tactilefeedback member of the handle assembly, shown in an position following acomplete actuation of the trigger;

FIG. 49 is a longitudinal, cross-sectional view of the end effector anda distal end of endoscopic assembly, illustrating an implanting of asurgical anchor through a surgical mesh and into underlying tissue;

FIG. 50 is a perspective illustration showing the anchoring and/orfixation of a surgical mesh to underlying tissue with a plurality ofsurgical fasteners;

FIG. 51 is a perspective view of a distal end of another embodiment ofan endoscopic surgical device illustrating an alternate end effector andan alternate complementary elongate body portion, wherein the endeffector is shown separated from the elongate body portion;

FIG. 52 is a perspective view of the end effector of the endoscopicsurgical device of FIG. 51;

FIG. 53 is a perspective view of the end effector of FIG. 52 with anouter tube of the end effector removed therefrom;

FIG. 54 is a perspective view of a portion of the endoscopic surgicaldevice of FIG. 51 with a proximal end of the end effector shownconnected to a distal end of the elongate body portion, the elongatebody portion shown in an advanced position;

FIG. 55 is a perspective view of a portion of the endoscopic surgicaldevice of FIG. 51 with the proximal end of the end effector shownconnected to the distal end of the elongate body portion, the elongatebody portion shown in a retracted position;

FIG. 56 is a side, elevational view of an embodiment of a shipping wedgein accordance with the present disclosure;

FIG. 57A is a top, perspective view of the shipping wedge of FIG. 56with the end effector of FIG. 52 shown disposed within and coupled tothe shipping wedge;

FIG. 57B is a side, cross-sectional view as taken along 57B-57B of FIG.57A;

FIG. 58A is a top, perspective view of the shipping wedge of FIG. 56with the end effector of FIG. 52 shown coupled to the shipping wedge andwith the elongate body portion of the endoscopic surgical device of FIG.51 being positioned within the shipping wedge relative to the endeffector;

FIG. 58B is a side, cross-sectional view as taken along 58B-58B of FIG.58A; and

FIGS. 59-62 are enlarged, progressive, side, cross-sectional viewsillustrating the end effector being coupled and secured to the elongatebody portion and removed from the shipping wedge.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed endoscopic surgical device isdescribed in detail with reference to the drawings, in which likereference numerals designate identical or corresponding elements in eachof the several views. As used herein the term “distal” refers to thatportion of the endoscopic surgical device that is farther from the user,while the term “proximal” refers to that portion of the endoscopicsurgical device that is closer to the user.

Non-limiting examples of endoscopic surgical devices which may includearticulation joints according to the present disclosure include manual,mechanical and/or electromechanical surgical tack appliers (i.e.,tackers) and the like.

Referring initially to FIGS. 1-4, a surgical anchor for use with thesurgical tack applier of the present disclosure is illustrated andgenerally designated as anchor 100. As seen in FIGS. 1-4, anchor 100includes a head section 110, a mesh retention section 120, and athreaded tissue-snaring section 130. Head section 110 includes a pair ofopposing threaded sections 112 a, 112 b having respective radially,outer, helical head threads 114 a, 114 b, and a pair of opposing open orslotted sections 116 a, 116 b. A distal surface of head section 110 isformed onto or integral with a proximal end of mesh retention section120.

Mesh retention section 120 of anchor 100 extends from and between adistal end or surface of head section 110 and a proximal end oftissue-snaring section 130. Mesh retention section 120 functions tolock, anchor or otherwise retain a surgical mesh (not shown) on toanchor 100 when anchor 100 is screwed into the mesh to a depth past aproximal-most segment 138 of tissue-snaring thread 132 of tissue-snaringsection 130. This is achieved because there is no thread located in meshretention section 120 that would allow anchor 100 to be unscrewed orbacked out from the mesh.

Mesh retention section 120 has a cylindrical or conical transversecross-sectional profile. Mesh retention section 120 includes atransverse radial dimension, relative to a central longitudinal axis ofanchor 100, that is smaller than a transverse radial dimension of headsection 110, and smaller than a transverse radial dimension ofproximal-most segment 138 of tissue-snaring thread 138.

Threaded tissue-snaring section 130 of anchor 100 includes helicalthreads 132 formed onto a tapered truncated body section 134. A distalpoint or tip 136 defines the terminus of the distal most tissue-snaringthread 132.

As seen in FIG. 4, body section 134 of tissue-snaring section 130 istapered, i.e., becoming smaller toward the distal end of threadedtissue-snaring section 130, and terminates or truncates to a distaltruncation point “TP”, prior to reaching an apex or tip of anchor 100.Body section 134 includes a concave taper such that, for a given length,a minimum diameter body section 134 is defined upon truncation thereofwhich is approximately less than 0.01 inches.

Anchor 100 includes a transverse dimension “D”, of a distal-most threadin the threaded tissue-snaring section 130 which is as large as designconstraints will allow or approximately greater than 0.040 inches. Inaccordance with the present disclosure, a small truncated body diameterand a large value of “D” minimizes tissue indentation. Thetissue-snaring threads 132 terminate at distal tip 136, which is distalof the truncation point “TP” of body section 134.

By providing a distal tip 136 extending distally of truncation point“TP” of tissue-snaring section 130, a penetration of the mesh, by anchor100, is eased; and an indentation of the mesh into relatively softtissue, by anchor 100, is minimized, as compared to an anchor having anon-truncated body with tapered threads.

For a given force applied to a surgical mesh by the surgeon, exerting adistal force on a tack applier the larger the dimension “D” of anchor100 the less the pressure exerted to cause indentation of an underlyingtissue and surgical mesh.

Anchor 100 is non-cannulated and is constructed from a suitablebioabsorbable material, such as, polylactide, polyglycolide. Anchor 100is formed from a proprietary biocompatible co-polymer (Lactomer USS L1,Boehringer Ingelheim LR 704 S, or Boehringer Ingelheim LG-857).

Turning now to FIGS. 5-49, an endoscopic surgical device, in the form ofan endoscopic surgical tack applier or tacker, is shown generally as200. Tack applier 200 includes a handle assembly 210, and an endoscopicassembly 230 extending from handle assembly 210 and configured to storeand selectively release or fire a plurality of anchors 100 therefrom andinto mesh “M” overlying tissue “T”. (see FIG. 50).

As seen in FIGS. 5-14, handle assembly 210 includes a handle housing 212formed from a first half-section 212 a and a second half section 212 bjoined to one another. First half-section 212 a and second half section212 b of handle housing 212 may be joined to one another using knowmethods by those of skill in the art, including and not limited towelding, fasteners (i.e., screws) and the like.

Handle assembly 210 includes a trigger 214 pivotably connected to handlehousing 212, at a location remote from endoscopic assembly 230. Handleassembly 210 includes a biasing member 222 configured for maintainingtrigger 214 in an extended or un-actuated position. Biasing member 222is also configured to have a spring constant sufficient to returntrigger 214 to the un-actuated position.

Trigger 214 defines a gear rack 214 a formed thereon at a locationopposite or remote from the pivot of trigger 214. Gear rack 214 a oftrigger 214 is configured for operative engagement with a pinion gear216 rotatably supported in handle housing 212. Gear rack 214 a andpinion gear 216 are dimensioned such that one complete squeeze oftrigger 214 results in one complete revolution of pinion gear 216.

As seen in FIGS. 7, 9, 11, 47 and 48, handle assembly 210 includes atiming system 270 associated therewith. Timing system 270 includes araceway 214 c formed in a surface of trigger 214. Raceway 214 c definesa plurality of steps 214 d therealong, and a home position 214 e (FIGS.9 and 48) formed therein.

Timing system 270 includes a resilient and deflectable arm 272 having afirst end 272 a operative connected or disposed in raceway 214 c andthat is in contact with steps 214 d as first end 272 a thereof travelsaround raceway 214 c. Deflectable arm 272 further includes a second end272 b that is connected to handle housing half 212 b. Raceway 214 c oftrigger is configured such that when trigger 214 is in a fullyun-actuated position, first end 272 a of deflectable arm 272 is locatedin the home position 214 e of raceway 214 c.

In operation, as seen in FIGS. 47 and 48, when trigger 214 is in thefully un-actuated position, as mentioned above, first end 272 a ofdeflectable arm 272 is located in the home position 214 e of raceway 214c. Then, as trigger 214 is actuated, first end 272 a of arm 272 ridesthrough and/or along raceway 214 c (in a single direction) formed intrigger 214. First end 272 a of arm 272 moves uni-directionally oversteps 214 d of raceway 214 c, such that, if trigger 214 is releasedafter a partial squeeze, first end 272 a of arm 272 can not movebackwards or in reverse through raceway 214 c due to steps 214 d andtrigger 214 can not return to the fully un-actuated position.

As so configured and operable, and as will be described in detail below,end effector or SULU 300 may only be removed and replaced when trigger214 is in the fully un-actuated, home and locked position. As such, anend effector or SULU 300 can not be removed or replaced or loaded on/inhandle assembly 200 while trigger 214 is in a short-stroked condition(i.e., partially actuated).

Additionally, as first end 272 a of arm 272 moves over steps 214 d ofraceway 214 c, first end 272 a of arm 272 snaps over steps 214 d andcreates an audible sound/click and/or a tactile vibration for thesurgeon. It is contemplated that timing system 270 includes sufficientsteps 214 d in raceway 214 c so as to create an audible/tactileindication when trigger 214 is in a fully un-actuated home or lockoutposition (for loading/unloading end effector or SULU 300); after trigger214 has been fully actuated to fire a singe surgical anchor 100; andwhen trigger 214 is reset to the fully un-actuated home position(wherein trigger 214 may once again be locked) and ready to fire anothersurgical anchor 100.

As seen in FIGS. 7 and 9-12, handle assembly 210 includes a pinion gear216 having an arm 216 a extending radially therefrom and a cam or ramp216 b extending/projecting from arm 216 a. Cam 216 b includes a frontend 216 c having a height defining a shoulder, and tail end 216 dtapering into arm 216 a.

As seen in FIGS. 7-11 and 14, handle assembly 210 further includes afirst bevel gear 218, in the form of a crown gear, operativelyengaged/associated with pinion gear 216. First bevel gear 218 defines anarcuate slot 218 a formed in a face 218 d thereof for selectivelyreceiving and engaging cam 216 b of pinion gear 216. Slot 218 a includesa front end wall 218 b configured to engage front end 216 c of cam 216 bof pinion gear 216, and tapers along a length thereof to be flush withface 218 d of first bevel gear 218.

In use, as trigger 214 is actuated, gear rack 214 a thereof is moved inan axial or arcuate first direction to thereby rotate pinion gear 216,meshed therewith, in a first direction. As pinion gear 216 is rotated inthe first direction, front end 216 c of cam 216 b of pinion gear 216 isrotated in a first direction until front end 216 c engages or contactsfront end wall 218 a of slot 218 b of first bevel gear 218. After frontend 216 c of pinion gear 216 engages or contacts front end wall 218 a ofslot 218 b of first bevel gear 218, continued rotation of pinion gear216 in the first direction results in concomitant rotation of firstbevel gear 218 in a first direction. At this point, first bevel gear 218continues to rotate in the first direction so long as trigger 214 isbeing actuated and gear rack 214 a is moving in the first direction.

When actuation of trigger 214 is stopped, either prior to completeactuation or following complete actuation, rotation of first bevel gear218, in the first direction, is also stopped.

Upon the completion of a partial or complete actuation of trigger 214and a release thereof, gear rack 214 a thereof is moved in a seconddirection (opposite the first direction) to thereby rotate pinion gear216 in a second direction. As pinion gear 216 is rotated in the seconddirection rear end 216 d of cam 216 b thereof slides along slot 218 b offirst bevel gear 218, and if the rotation in the second direction issufficient, slides out of slot 218 b of bevel gear 218 and along face218 d of first bevel gear 218.

If trigger 214 was fully actuated, a complete release of trigger 214,and return to the fully un-actuated position, wherein first end 272 a ofdeflectable arm 272 is returned to the home position 214 e of raceway214 c, will result in pinion gear 216 making a complete revolution, inthe second direction, until front end 216 c of cam 216 b of pinion gear216 clears front end wall 218 a of slot 218 b of first bevel gear 218 tothereby re-enter slot 218 b of first bevel gear 218.

As seen in FIGS. 8 and 11, handle assembly 210 of tack applier 200 isprovided with a ratchet mechanism 260 which is configured to inhibit orprevent inner shaft assembly 238 from backing-out or reversing afteranchor 100 has been at least partially driven into tissue. Ratchetmechanism 260 includes, as seen in FIGS. 8 and 11, a series of ratchetteeth 218 f formed on a rear surface 218 e of first bevel gear 218.

Ratchet mechanism 260 further includes a spring clip 262 secured withinhandle assembly 210. Spring clip 262 includes a resilient finger 262 aconfigured for engagement with ratchet teeth 218 f formed on rearsurface 218 e of first bevel gear 218.

Each ratchet tooth 218 f includes a shallow angled side and a steepangled side. In this manner, resilient finger 262 a of spring clip 262engages with ratchet teeth 218 f in such a manner that as first bevelgear 218 is rotated, in a first direction resilient, finger 262 a ofspring clip 262 cams over the shallow angled side of ratchet teeth 218f. Also, if first bevel gear 218 is rotated in a second direction(opposite to the first direction), resilient finger 262 a of spring clip262 stops against the steep angled side of ratchet teeth 218 f therebypreventing or inhibiting first bevel gear 218 from rotating in thesecond direction. As such, any reverse rotation or “backing-out” ofanchor 100 or inner shaft assembly 238 (tending to cause first bevelgear 218 to rotate in the second direction), during a driving or firingstroke, is inhibited or prevented.

In an alternate embodiment, first bevel gear 218 may be maintained fromrotating in the second or opposite direction, upon the rotation ofpinion gear 216, in the second direction, due to a coefficient of staticfriction between first bevel gear 218 and a surface of handle housing212, or a coefficient of static friction between first bevel gear 218and a pin upon which first bevel gear 218 is supported, which will tendto maintain first bevel gear 218 stationary. Such a configuration andassembly functions as a ratchet mechanism or the like for tack applier200.

With reference to FIGS. 6, 7 and 9-11, handle assembly 210 furtherincludes a second or pinion-bevel gear 220 having gear teeth 220 aoperatively engaged or meshed with gear teeth 218 c formed at the outerradial edge and on front face 218 d of first bevel gear 218.Pinion-bevel gear 220 is secured to a proximal end of an inner shaftassembly 238 of anchor retaining/advancing assembly 230 (see FIG. 15).In an embodiment, pinion-bevel gear 220 is keyed to proximal end ofinner shaft assembly 238 of anchor retaining/advancing assembly 230 suchthat inner shaft assembly 238 is capable of axial displacement relativeto pinion-bevel gear 220 and is prevented from rotation relative topinion-bevel gear 220.

In use, as described above, upon squeezing of trigger 214, gear rack 214a thereof causes pinion gear 216 to rotate in the first direction.Rotation of pinion gear 216, in the first direction, results in rotationof first bevel gear 218 in the first direction and, in turn, rotation ofpinion-bevel gear 220 in a first direction. As pinion-bevel gear 220 isrotated in the first direction, pinion-bevel gear 220 transmits therotation to inner shaft assembly 238 of anchor retaining/advancingassembly 230.

As seen in FIGS. 5-11 and 13, handle assembly 210 includes a button 240supported on handle housing 212 and being configured to permit andinhibit actuation of trigger 214, and for effectuating aloading/retention and a release/removal of an end effector 300 to anchorretaining/advancing assembly 230. Button 240 includes a pin 240 aslidably supported in handle housing 212. Pin 240 a is oriented in adirection orthogonal to the longitudinal axis of anchorretaining/advancing assembly 230. As seen in FIGS. 38-41, pin 240 a hasa length such that when button 240 is in a first position, a first endof pin 240 a extends from a first side of handle housing 212, and whenbutton 240 is in a second position, a second end of pin 240 a extendsfrom a second side of handle housing 212.

As seen in FIGS. 13 and 38-41, button 240 includes a plate 240 bsupported on and connected to pin 240 a. Plate 240 b defines an elongateslot 240 c therein, through which a stem 220 a of pinion-bevel gear 220extends. Elongate slot 240 c of plate 240 b defines a major axis whichis parallel relative to a longitudinal axis of pin 240 a. In use, as pin240 a is moved between the first position and the second position, plate240 b is moved between respective first and second positions.

Button 240 includes a first detent or recess 240 d defined in plate 240b that is engaged by a biasing member 242 when button 240 is in thefirst position, and a second detent or recess 240 e defined in plate 240b that is engaged by biasing member 242 when button 240 is in the secondposition. The engagement of biasing member 242 in either first detent240 d or second detent 240 e of button 240 functions to help maintainbutton 240 in either the first or second position.

In an embodiment, biasing member 242 may be in the form of a plungerspring, and, as seen in FIGS. 33 and 42, in another embodiment, biasingmember 242 may be in the form of a torsion spring. A torsion spring iscontemplated over a plunger spring in order to reduce overall costs ofsurgical tacker 200.

As seen in FIGS. 8, 13, 33 and 38-42, button 240 includes a first wall240 f extending from plate 240 b, and a second wall 240 g extending fromplate 240 b. In use, when button 240 is in the first position, firstwall 240 f thereof blocks or inhibits movement of a load/release slider244, and when button 240 is in the second position, first wall 240 fthereof permits movement of load/release slider 244. Similarly, in use,when button 240 is in the second position (only achievable when trigger214 is in a fully un-actuated or home position), second wall 240 gthereof blocks or inhibits actuation of trigger 214 by second wall 240 gextending into a notch 214 b of trigger 214; and when button 240 is inthe first position, second wall 240 f is clear of notch 214 b of trigger214 to permit actuation of trigger 214.

As seen in FIGS. 5-11, 13 and 38-42, handle assembly 210 includes aload/release slider 244 slidably supported on handle housing 212 andbeing configured to effectuate a loading/retention and a release/removalof an end effector 300, in the form of a single use loading unit (SULU)or disposable loading unit (DLU), as will be discussed in greater detailbelow. Slider 244 includes a first stem 244 a extending proximallytherefrom and toward button 240. Specifically, first stem 244 a ofslider 244 is in axial registration with first wall 240 f extending fromplate 240 b of button 240 when button 240 is in the first position (seeFIG. 39), and out of axial registration with first wall 240 f of button240 when button 240 is in the second position (see FIG. 41).

Slider 244 further includes a second stem 244 b extending therefrom in adirection toward inner shaft assembly 238 of anchor retaining/advancingassembly 230. As seen in FIGS. 15 and 42, inner shaft assembly 238supports a pair of axially spaced apart radial flanges 238 d, 238 ewhich bookend (i.e., one flange being distal and one flange beingproximal of second stem 244 b).

In use, as seen in FIGS. 41 and 42, when button 240 is in the secondposition (wherein trigger 214 is locked in the fully un-actuatedposition) such that first stem 244 a of slider 244 is out of axialregistration with first wall 240 f of button 240, slider 244 is free tomove between a first or distal position and a second or proximalposition. As slider 244 is moved from the first position to the secondposition thereof, second stem 244 b of slider 244 exerts a force onproximal radial flange 238 d of inner shaft assembly 238 to urge innershaft assembly 238 proximally from a respective first position to arespective second position. It follows that as slider 244 is moved fromthe second position to the first position thereof, second stem 244 b ofslider 244 exerts a force on distal radial flange 238 e of inner shaftassembly 238 to urge inner shaft assembly 238 distally from therespective second position to the respective first position.

In accordance with the present disclosure, as inner shaft assembly 238is moved between the respective first and second positions thereof,inner shaft assembly 238, being connected to coupling member 238 cresults in connecting member 238 c also moving between a respectivefirst position and a respective second position.

Slider 244 may be biased to the first or distal position by a biasingmember 245 (see FIG. 42).

As seen in FIGS. 5, 6, 8, 15, 17, 33-35 and 45, handle assembly 210includes an articulation knob 246 rotatably supported on handle housing212. Articulation knob 246 defines an inner helical thread 246 a Innerhelical thread 246 a meshingly receives or engages an outer thread 247 aof a connection nut 247 that is non-rotatably connected to proximal tubeportion 234 a of inner tube assembly 234 of anchor retaining/advancingassembly 230. Connection nut 247 may be keyed to articulation knob 246so as to not rotate relative to articulation knob 246 as articulationknob 246 is rotated. Alternatively, the surgeon may manually grip adistal end of connection nut 247 (which is projecting/extending distallyof articulation knob 246) as articulation knob 246 is rotated.

In use, as seen in FIGS. 45 and 46, with connection nut 247 retainedagainst rotation about the longitudinal axis, as articulation knob 246is rotated in a first direction, connection nut 247 travels along innerhelical thread 246 a of articulation knob 246 to cause innerarticulation tube assembly 234 to move in a respective first or distalaxial direction; and as articulation knob 246 is rotated in a seconddirection, connection nut 247 travels along inner helical thread 246 aof articulation knob 246 to cause inner articulation tube assembly 234to move in a respective second or proximal axial direction. Inaccordance with the present disclosure, rotation of articulation knob246 in the respective first and second directions results in thearticulating and straightening of anchor retaining/advancing assembly230, as will be discussed in greater detail below.

Turning now to FIGS. 15, 16, 32, 33 and 42-46, as seen therein,endoscopic assembly 230 includes an outer tube 231, an outer supporttube assembly 232 disposed within outer tube 231, an inner articulationtube assembly 234, and an inner shaft assembly 238. Outer support tubeassembly 232 includes a proximal support tube portion 232 a secured toand extending from handle housing 212, and a distal support tube portion232 b pivotally connected to proximal tube portion 232 a by a pivot pin232 c (see FIGS. 15 and 16) at an articulation joint 250.

As seen in FIGS. 15, 16, 43 and 44, distal support tube portion 232 bsupports a ball detent 233 in an outer surface thereof. Ball detent 233functions to selectively secure and retain end effector 300 toendoscopic assembly 230. In use, as will be discussed in greater detailbelow, as seen in FIGS. 37 and 42, ball detent 233 is acted on by anouter camming surface/relief 238 c ₁ of coupling member 238 which actson ball detent 233 to move ball detent 233 radially outward when innershaft assembly 238 is a distal position.

Inner articulation tube assembly 234 includes a proximal tube portion234 a concentrically and slidably disposed within proximal tube portion232 a of outer support tube assembly 232. As seen in FIG. 33, proximalend 234 b of proximal tube portion 234 a is non-rotatably connected toconnection nut 247.

Inner articulation tube assembly 234 includes an articulation link 235having a proximal end 235 a pivotally connected to a distal end ofproximal tube portion 234 a, and a distal end 235 b pivotally connectedto distal tube portion 232 b of outer support tube assembly 232. Distalend 235 b of articulation link 235 is pivotally connected to distal tubeportion 232 b of outer support tube assembly 232 at a location offsetfrom the central longitudinal axis of anchor retaining/advancingassembly 230, in a direction substantially away from pivot pin 232 c ofarticulation joint 250.

In operation, as seen in FIGS. 45 and 46, upon an axial translation ofproximal tube portion 234 a, for example in a proximal direction, due toa rotation of articulation knob 246 and proximal axial movement ofconnection nut 247 as described above, proximal tube portion 234 a actsor pulls on articulation link 235 to cause articulation link 235 totranslate in a proximal direction. As articulation link 235 is axiallytranslated in a proximal direction, articulation link 235 acts or pullson distal tube portion 232 b of outer support tube assembly 232 to causedistal tube portion 232 b to pivot about a pivot axis of pivot pin 232c. As distal tube portion 232 b is pivoted, distal tube portion 232 bcauses end effector 300 to be moved to an articulated orientationrelative to the central longitudinal axis of anchor retaining/advancingassembly 230.

It follows that upon an axial translation of proximal tube portion 234 ain a distal direction, due to a distal movement of slider 244, asdescribed above, proximal tube portion 234 a acts or pushes onarticulation link 235 to cause articulation link 235 to translate in adistal direction. As articulation link 235 is axially translated in adistal direction, articulation link 235 acts or pushes on distal tubeportion 232 b of outer support tube assembly 232 to cause distal tubeportion 232 b to pivot about a pivot axis of pivot pin 232 c. As distaltube portion 232 b is pivoted, distal tube portion 232 b causes endeffector 300 to be returned to a non-articulated orientation relative tothe central longitudinal axis of anchor retaining/advancing assembly230.

In accordance with the present disclosure, distal tube portion 232 b ofanchor retaining/advancing assembly 230 is pivotable in a singledirection relative to proximal tube portion 232 a of anchorretaining/advancing assembly 230.

With reference to FIGS. 15, 19, 32, 33 and 35-46, inner actuation shaftassembly 238 includes a proximal rigid shaft portion 238 a, a distalflexible shaft portion 238 b non-rotatably connected to and extendingfrom a distal end of proximal rigid shaft portion 238 a, and a couplingmember 238 c non-rotatably connected to a distal end of distal flexibleshaft portion 238 b. Second or pinion-bevel gear 220 is non-rotatablyconnected to a proximal end of proximal rigid shaft portion 238 a ofinner actuation shaft assembly 238. Inner actuation shaft assembly 238is configured such that distal flexible shaft portion 238 b extendsacross and beyond articulation joint 250.

Desirably, coupling member 238 c is rotatably and slidably supported indistal tube portion 232 b of outer support tube assembly 232 so as toaccommodate and/or account for variations in length of distal flexibleshaft portion 238 b when distal flexible shaft portion 238 b is in aflexed condition. Coupling member 238 c is substantially tongue shapedand extends in a distal direction distally from distal tube portion 232b of outer support tube assembly 232. Coupling member 238 c isconfigured for non-rotatable connection to inner tube 338 of endeffector 300, as will be discussed in greater detail below.

Distal flexible shaft portion 238 b is fabricated from a torsionallystiff and flexible material, such as, for example, stainless steel.

It is contemplated that distal flexible shaft portion 238 b may have anouter diameter of about 0.08′. Meanwhile, anchor retaining/advancingassembly 230 has an outer diameter of about 0.22′. A ratio of the outerdiameter of distal flexible shaft portion 238 b to the outer diameter ofanchor retaining/advancing assembly 230 is about 2.8.

Inner actuation shaft assembly 238 is configured to perform at least apair of functions, a first function relating to the securing and releaseof an end effector or SULU 300 to distal tube portion 232 b of outersupport tube assembly 232 upon an axial translation thereof, and asecond function relating to the firing of fasteners 100 from endeffector or SULU 300 when end effector or SULU 300 is coupled to distaltube portion 232 b of outer support tube assembly 232 upon a rotationthereof.

In order to prepare surgical tacker 200 for receipt of end effector orSULU 300 or to replace a spent end effector or SULU 300 with a new endeffector or SULU 300, as seen in FIGS. 38-44, and as mentioned above,trigger 214 must be in a fully un-actuated position. With trigger 214 inthe fully un-actuated position, button 240 is moved from the firstposition to the second position (as described above) such that trigger214 is prevented from actuation and such that slider 244 is free tomove. With button 240 in the second position, slider 244 is moved fromthe first position to the second position (as described above). Asslider 244 is moved to the second position, second stem 244 b of slider244 exerts a force on proximal radial flange 238 d of inner shaftassembly 238 to urge inner shaft assembly 238, and in turn couplingmember 238 a thereof, proximally from a respective first position to arespective second position. As coupling member 238 a is moved from thefirst position to the second position, ball detent 233 is free to dropor move radially inward of outer tube 231 as outer cammingsurface/relief 238 c ₁ of coupling member 238 is moved into axialregistration with ball detent 233. With ball detent 233 free to drop ormove radially inward, end effector or SULU 300 may be fully coupled todistal support tube portion 232 b of anchor retaining/advancing assembly230.

Once again, as mentioned above, as so configured and operable, endeffector or SULU 300 may only be removed and replaced when trigger 214is in the fully un-actuated, home and locked position. As such, endeffector or SULU 300 can not be removed or replaced or loaded whiletrigger 214 is in a short-stroked condition (i.e., partially actuated).

With a new end effector or SULU 300 fully coupled to distal support tubeportion 232 b of anchor retaining/advancing assembly 230, slider 244 ismoved from the second position to the first position to secure or lockend effector or SULU 300 to distal support tube portion 232 b of anchorretaining/advancing assembly 230. In particular, as slider 244 is movedto the first position, second stem 244 b of slider 244 exerts a force ondistal radial flange 238 e of inner shaft assembly 238 to urge innershaft assembly 238, and in turn coupling member 238 a thereof, distallyfrom second position to first position. As coupling member 238 a ismoved from the second position to the first position, ball detent 233 isurged by outer camming surface/relief 238 c ₁ of coupling member 238 tomove ball detent 233 radially outward. As ball detent 233 moves radiallyoutward a portion of ball detent 233 enters an aperture 332 c of endeffector or SULU 300 to secure end effector or SULU 300 to distalsupport tube portion 232 b of anchor retaining/advancing assembly 230.With end effector or SULU 300 coupled to distal support tube portion 232b of anchor retaining/advancing assembly 230, button 240 is moved fromthe second position to the first position (as described above) such thatslider 244 is prevented from actuation and such that trigger 214 is freeto move.

Turning now to FIGS. 5, 6, 15, 17-27, 32, 36, 37, 43, 44 and 46, endeffector 300, in the form of a SULU or DLU, is shown and will bedescribed herein. End effector 300, as mentioned above, is selectivelyconnectable to distal tube portion 232 b of outer support tube assembly232.

End effector or SULU 300 includes an outer tube 332 defining a lumen 332a therethrough and being configured and dimensioned (i.e., substantiallyrectangular or dog bone shaped) to receive distal tube portion 232 b ofouter support tube assembly 232 and coupling member 238 c of anchorretaining/advancing assembly 230 therein. As seen in FIG. 19, outer tube332 defines a proximal key slot 332 b for engagement with a key 232 cformed in distal tube portion 232 b of outer support tube assembly 232.In use, when end effector or SULU 300 is connected to distal tubeportion 232 b of outer support tube assembly 232 key slot 332 b and key232 c engage with one another to properly align end effector or SULU 300and anchor retaining/advancing assembly 230 to one another.

End effector or SULU 300 further includes a spiral or coil 336 fixedlydisposed within a distal portion of outer tube 332. A pair of axiallyspaced apart retention rings 337 a, 337 b is also fixedly disposedwithin outer tube 332 at a location proximal of coil 336.

End effector or SULU 300 also includes an inner tube 338 rotatablydisposed within coil 336 Inner tube 338 defines a lumen therethrough,and includes a proximal end portion 338 a and a splined distal endportion 338 b. Proximal end portion 338 a of inner tube 338 isconfigured and dimensioned to slidably receive coupling member 238 c ofanchor retaining/advancing assembly 230 therein Inner tube 338 includesa plurality of retention tabs 338 c projecting radially outwardtherefrom and which snap beyond one of the pair of retention rings 337a, 337 b, when inner tube 338 is assembled with outer tube 332. In thismanner, outer tube 332 and inner tube 338 are axially fixed and yetrotatable relative to one another.

Distal end portion 338 a of inner tube 338 is slotted, defining a pairof tines 338 a ₁ and a pair of channels 338 a ₂. Distal end portion 338a of inner tube 338 is capable of accepting a plurality of anchors 100within inner tube 338. In particular, anchors 100 are loaded into endeffector or SULU 300 such that the pair of opposing threaded sections112 a, 112 b of anchors 100 extend through respective channels 338 a ₂of distal end portion 338 a of inner tube 338 and are slidably disposedwithin the groove of coil 336, and the pair of tines 338 a ₁ of distalend portion 338 a of inner tube 338 are disposed within the pair ofslotted sections 116 a, 116 b of anchors 100. Each anchor 100 is loadedinto end effector or SULU 300 such that adjacent anchors 100 are not incontact with one another so as to not damage distal tips 136.

In use, as inner tube 338 is rotated, about its longitudinal axis, withrespect to coil 336, the pair of tines 338 a ₁ of inner tube 338transmit the rotation to anchors 100 and advance anchors 100 distallyowing to head threads 114 a, 114 b of anchors 100 engaging with coil336.

In an operation of surgical tacker 200, as seen in FIG. 49, with endeffector or SULU 300 operatively connected to distal tube portion 232 bof outer support tube assembly 232 of anchor retaining/advancingassembly 230, as inner shaft assembly 238 is rotated due to an actuationof trigger 214, as described above, said rotation is transmitted toinner tube 338 of end effector or SULU 300 via coupling member 238 c ofanchor retaining/advancing assembly 230. Again, as inner tube 338 isrotated, about its longitudinal axis, with respect to coil 336, the pairof tines 338 a ₁ of inner tube 338 transmit the rotation to the entirestack of anchors 100 and advance the entire stack of anchors 100distally, owing to head threads 114 a, 114 b of anchors 100 engagingwith coil 336.

In accordance with the present disclosure, the components of surgicaltacker 200, and anchors 100 are dimensioned such that a single completeand full actuation of trigger 214 results in a firing of a singe anchor100 (i.e., the distal-most anchor of the stack of anchors 100 loaded inend effector or SULU 300) from end effector or SULU 300.

Surgical tacker 200 may be repeatedly fired to fire anchors from endeffector 300 until the surgical procedure is complete or until endeffector or SULU 300 is spent of anchors 100. If end effector or SULU300 is spent of anchors 100, and if additional anchors 100 are requiredto complete the surgical procedure, spent end effector or SULU 300 maybe replaced with a new (i.e., loaded with anchors 100) end effector orSULU 300.

As seen in FIGS. 40-44, in order to replace spent end effector or SULU300 with a new end effector or SULU 300, with trigger 214 in the fullyun-actuated position (as described above, the surgeon actuates or slidesbutton 244 to release the spent end effector or SULU 300, decouples endeffector or SULU 300 from anchor retaining/advancing assembly 230, loadsor connects a new end effector or SULU 300 to anchor retaining/advancingassembly 230 (by fitting proximal end portion 338 a of inner tube 338over coupling member 238 c of anchor retaining/advancing assembly 230),and releases button 244 to retain the new end effector or SULU 300 onanchor retaining/advancing assembly 230. Since trigger 214 is in thefully un-actuated position with the loading of a new end effector orSULU 300, timing system 270 is re-set such that each fully actuation oftrigger 214 results in the firing of a single anchor 100.

It is contemplated that end effector or SULU 300 may only be connectedor coupled to distal tube portion 232 b of outer support tube assembly232 of anchor retaining/advancing assembly 230 while anchorretaining/advancing assembly 230 is in the non-articulated condition.

In accordance with the present disclosure, with end effector or SULU 300connected or coupled to distal tube portion 232 b of outer support tubeassembly 232 of anchor retaining/advancing assembly 230, articulationknob 246 is rotated or held in place such that anchorretaining/advancing assembly 230 is in a non-articulated condition.

Additionally, in accordance with the present disclosure, with endeffector or SULU 300 connected or coupled to distal tube portion 232 bof outer support tube assembly 232 of anchor retaining/advancingassembly 230, end effector or SULU 300 is introduced into a targetsurgical site while in the non-articulated condition. With end effectoror SULU 300 disposed within the target surgical site, the surgeon mayremotely articulate end effector or SULU 300 relative to anchorretaining/advancing assembly 230. Specifically, as seen in FIGS. 45 and46, the surgeon rotates articulation knob 246 to axially displaceconnection nut 247 and proximal tube portion 234 a of inner articulationtube assembly 234 to move in the proximal axial direction. As proximaltube portion 234 a is moved in the proximal axial direction, proximaltube portion 234 a acts or pulls on articulation link 235 to causearticulation link 235 to translate in a proximal direction. Asarticulation link 235 is axially translated in a proximal direction,articulation link 235 acts or pulls on distal tube portion 232 b ofouter support tube assembly 232 to cause distal tube portion 232 b topivot about a pivot axis of pivot pin 232 c. As distal tube portion 232b is pivoted, distal tube portion 232 b causes end effector 300 to bemoved to an articulated orientation relative to the central longitudinalaxis of anchor retaining/advancing assembly 230.

Turning now to FIGS. 28-30, in accordance with the present disclosure, ashipping wedge 400 may be provided which is configured and dimensionedto releasably connect to end effector or SULU 300, to inhibit prematurerotation of inner tube 338 of end effector or SULU 300, and to helpfacilitate loading/unloading of end effector or SULU 300 to/from distaltube portion 232 b of anchor retaining/advancing assembly 230.

Shipping wedge 400 includes a handle portion 402 and a coupling member404 integrally formed with or secured to handle portion 402. Couplingmember 404 is substantially tubular having a substantially C-shapedtransverse cross-sectional profile. Coupling member 404 defines alongitudinally extending opening or gap 404 a therealong. Handle portion404 defines a longitudinal axis that is substantially orthogonal to thelongitudinal axis of coupling member 404.

Coupling member 404 has a diameter sufficient to accommodate endeffector or SULU 300 therein and along. Also, gap 404 a of couplingmember 404 has a dimension, which together with the materials ofconstruction of at least coupling member 404, allows for coupling member404 to be snapped-over end effector or SULU 300. It is envisioned thatat least coupling member 404 may be fabricated from a polymeric or othersubstantially rigid and resilient material.

As seen in FIGS. 29 and 30, shipping wedge 400 includes a wedge, spikeor nub 406 extending radially into coupling member 404. In particular,wedge 406 extends or projects in a direction substantially parallel tothe longitudinal axis of handle portion 402. Wedge 406 has a lengthsufficient such that, when shipping wedge 400 is attached to endeffector or SULU 300, wedge 406 enters an aperture 332 d (see FIGS. 19,22, 29 and 30) formed in outer tube 332 of end effector or SULU 300.

Additionally, when shipping wedge 400 is attached to end effector orSULU 300, wedge 406 extends to be in close proximity to or in contactwith proximal end portion 338 a of inner tube 338 of end effector orSULU 300. By extending this amount, wedge 406 inhibits rotation of innertube 338 relative to outer tube 332 by blocking or contacting proximalend portion 338 a of inner tube 338 if inner tube 338 experiences anyrotation relative to outer tube 332.

Also, when shipping wedge 400 is attached to end effector or SULU 300,and with wedge 406 blocking rotation of inner tube 338 of end effectoror SULU 300, shipping wedge 400 facilitates a loading/unloading of endeffector or SULU 300 to/from distal tube portion 232 b of anchorretaining/advancing assembly 230. During loading of end effector or SULU300 to distal tube portion 232 b of anchor retaining/advancing assembly230, shipping wedge 400 functions to fix an angular orientation ofproximal end portion 338 a of inner tube 338 for proper alignment andorientation with coupling member 238 c of anchor retaining/advancingassembly 230.

In accordance with the present disclosure, it is contemplated thathandle assembly 100 may be replaced by an electromechanical controlmodule configured and adapted to drive the flexible drive cables to fireor actuate the surgical device. The electromechanical control module mayinclude at least one microprocessor, at least one drive motorcontrollable by the at least one microprocessor, and a source of powerfor energizing the at least one microprocessor and the at least onedrive motor.

Turning now to FIGS. 51-55, another embodiment of an endoscopic surgicaldevice, in the form of an endoscopic surgical tack applier or tacker, isshown generally as 500. Endoscopic surgical device 500 is similar toendoscopic surgical device 200 and is only described herein to theextent necessary to describe the differences in construction andoperation thereof. Likewise, another embodiment of an end effector isshown generally as 520. End effector 520 is similar to end effector 300and is only described herein to the extent necessary to describe thedifferences in construction and operation thereof.

With reference to FIG. 51, endoscopic surgical device 500 includes anelongate body portion 510 and an end effector 520 (e.g., single useloading unit) that can be selectively secured to a distal end ofelongate body portion 510.

Elongate body portion 510 includes an outer tube 512 and an inneractuation shaft 514 that is slidably positioned within outer tube 512.Outer tube 512 includes an inner surface 512 a and an outer surface 512b. Inner surface 512 a defines a lumen 512 c that extends longitudinallythrough outer tube 512 and supports inner actuation shaft 514. Outertube 512 defines a notch 512 d that extends between and across innersurface 512 a and outer surface 512 b in a distal end of outer tube 512.Inner actuation shaft 514 extends longitudinally through lumen 512 cbetween proximal and distal ends of outer tube 512. The distal end ofinner actuation shaft 514 includes an engagement member 516. An arm ortab 518 extends from engagement member 516. Arm 518 defines a recess 518a that extends at least partially therethrough.

As illustrated in FIGS. 51-53, end effector 520 includes an outer tube522 and a splined inner tube 524 rotatably positioned within outer tube522. Outer tube 522 includes an inner surface 522 a and an outer surface522 b Inner surface 522 a defines a lumen 522 c that extendslongitudinally through outer tube 522 between proximal and distal endsof outer tube 522. The distal end of outer tube 522 includes a distalopening 522 d. Outer tube 522 defines an opening 522 e that extendsbetween inner surface 522 a and outer surface 522 b in a proximalportion of outer tube 522. Splined inner tube 524 supports a spiral 336that is fixedly disposed within a distal portion of outer tube 522 andabout a pair of tines 530 of the splined inner tube 524, so that thepair of tines 530 and spiral 336 support a plurality of surgical anchors100 that are adapted for selective advancement through end effector 520.

As can be seen in FIG. 53, splined inner tube 524 includes a couplingmember 526 fixedly secured to inner surface 522 a of outer tube 522 at aproximal end thereof and includes a locking tab 526 a that extends froma proximal end of coupling member 526. As described above, splined innertube 524 includes a pair of tines 530 at a distal end thereof and anengagement member 532 at a proximal end thereof. The pair of tines 530includes a first tine 530 a and a second tine 530 b. First and secondtines 530 a, 530 b are spaced apart and define first and second channels530 c, 530 d therebetween that receive a portion of each of theplurality of anchors 100. Engagement member 532 includes an arm or tab534 extending longitudinally therefrom, and a pin 536 projectingperpendicularly to arm 534.

In use, as shown in FIGS. 54 and 55, inner actuation shaft 514 ofelongate body portion 510 is slidably movable relative to outer tube 512between an advanced position (FIG. 54) and a retracted position (FIG.55). In the advanced position, engagement member 516 of inner actuationshaft 514 is exposed or projects from outer tube 512. In the retractedposition, engagement member 516 of inner actuation shaft 514 isconcealed or housed within outer tube 512. More particularly, in theadvanced position, arm 518 of engagement member 516 is extended suchthat recess 518 a is exposed for receiving pin 536 of engagement member532.

To connect end effector 520 to elongate body portion 510, pin 536 ofengagement member 532 is inserted in recess 518 a of engagement member516 so that arm 534 of engagement member 532 is connected to arm 518 ofengagement member 516. After connecting end effector 520 to elongatebody portion 510, inner actuation shaft 514 can be moved to theretracted position which draws both engagement members 532, 516 withinouter tube 512 of elongate body portion 510. As such, locking tab 526 aof end effector 520 is received within notch 512 d of elongate bodyportion 510 to prevent outer tube 522 of end effector 520 from rotatingrelative to elongate body portion 510 upon a rotation of inner actuationshaft 514. Additionally, engagement member 516, 532 are housed withinouter tube 522 of end effector 520, thereby being inhibited fromseparating from one another.

A rotation of inner actuation shaft 114 rotates both engagement members516, 532 relative to outer tubes 512, 522 and coupling member 526 toimpart rotation to splined inner tube 524, and in turn, the pair oftines 530, for distally advancing the plurality of anchors 100 alongspiral 336 and individually deploying each of the plurality of anchors100 out of distal opening 522 d of outer tube 522 of end effector 520.

Turning now to FIG. 56, another embodiment of a shipping wedge is showngenerally as 600. Shipping wedge 600 includes an elongate first body610, and an angled second body 620 that extends from first body 610 atan angle relative to first body 610. More particularly, first body 610defines a longitudinal axis “A” that extends through opposed ends 610 a,610 b of elongate body 610. Angled body 620 defines a longitudinal axis“B” that extends through opposed ends of 620 a, 620 b of angled body620. Longitudinal axes “A” and “B” define an angle “α” therebetween.Although shown in FIG. 56 as an acute angle, angle “α” can be anysuitable angle.

Referring to FIGS. 57A and 57B, first body 610 includes a pair ofopposed sidewalls 612 a that is connected at a base 612 b. The pair ofopposed sidewalls 612 a defines a channel 614 therebetween to form aU-shape that is dimensioned to receive an elongate body such as elongatebody portion 510 of endoscopic surgical device 500. Channel 614 extendslongitudinally through first body 610. An alignment rib 616 extendsbetween the pair of opposed sidewalls 612 a and defines a passage 616 athat extends through alignment rib 616 and separates alignment rib 616into a pair of segments 616 b.

Angled body 620 includes a pair of opposed sidewalls 622 a that isconnected at a base 622 b. The pair of opposed sidewalls 622 a defines achannel 624 therebetween to form a U-shape that is dimensioned toreceive and retain an end effector, such as, end effector 520 (FIGS. 57Aand 57B). Channel 624 extends longitudinally through angled body 620such that channel 624 is angled relative to channel 614 (see FIG. 57B).Angled body 620 includes a protuberance 626 (e.g., a boss or nub) thatextends from an inner surface 622 c of base 622 b. Protuberance 626 canhave any suitable shape including circular and non-circular (e.g.,elliptical, polygonal, etc.) shapes.

A pair of alignment flanges 618 extend from opposed sidewalls 612 a offirst body 610 and opposed sidewalls 622 a of angled body 620 to formfunnel configurations that facilitate proper alignment of an endoscopicsurgical device such as endoscopic surgical device 500, or portionsthereof, relative to shipping wedge 600. As shown in FIG. 57A, eachalignment flange of the pair of alignment flanges 618 has a curvilineararrangement that extends outwardly from channels 614 and 624.

With continued reference to FIGS. 57A and 57B, although shipping wedge600 can be used with any suitable endoscopic surgical device, in anexemplary use with endoscopic surgical device 500, end effector 520 ofendoscopic surgical device 500 is secured within channel 624 of angledbody 620 (e.g., press fit). Protuberance 626 of angled body 620 ispositioned within opening 522 e of end effector 520 (and/or within firstand/or second channels 530 c, 530 d of end effector 520) to prevent endeffector 520 from translating through channel 624 of angled body 620and/or to prevent end effector 520, or portions thereof (e.g., outerand/or inner tube 522, 524 including the pair of tines 530), fromrotating within channel 624 of angled body 620. As can be appreciated,the protuberance 626 enables end effector 520 to maintain proper timing(e.g., tack/anchor deployment timing) during shipment and/or loadingprocesses of end effector 520. When the end effector 520 is securedwithin channel 624 of angled body 620, pin 536 of end effector 520 isaligned with alignment rib 616.

Referring also to FIGS. 58A-62, to remove end effector 520 from shippingwedge 600, in the advanced position of the elongate body portion 510 ofendoscopic surgical device 500, elongate body portion 510 can bepositioned relative to channel 614 so that the distal end of elongatebody portion 510 is longitudinally aligned with alignment rib 616. Moreparticularly, engagement member 516 of elongate body portion 510 abutsagainst alignment rib 616 of shipping wedge 600 to longitudinally alignarm 518 of engagement member 516 with passage 616 a. Elongate bodyportion 510 is then inserted (e.g., press fit) into channel 614 so thatarm 518 of elongate body portion 510, guided by alignment rib 616 ofshipping wedge 600, moves through passage 616 a toward pin 536 of endeffector 520 (FIGS. 59 and 60). As elongate body portion 510 engages endeffector 520, pin 536 inserts into recess 518 a of arm 518 so that endeffector 520 pivots relative to elongate body portion 510 and out ofchannel 624 of angled body 620 into axial alignment with elongate bodyportion 510 (FIGS. 60 and 61). As end effector 520 pivots out of channel624 of angled body 620, protuberance 626 of angled body 620 separatesfrom opening 522 e of end effector 520.

As seen in FIG. 62, with elongate body portion 510 connected to endeffector 520, elongate body portion 510 can be moved to the retractedposition to draw end effector 520 into engagement with elongate bodyportion 510 to secure the proximal end of end effector 520 within thedistal end of elongate body portion 510. Endoscopic surgical device 500,including both elongate body portion 510 and end effector 520, can thenbe withdrawn from shipping wedge 600, while beneath alignment rib 616,and through channel 614 of shipping wedge 600 to separate endoscopicsurgical device 500 from shipping wedge 600 (FIG. 62). Endoscopicsurgical device 500 can then be used to perform a surgical procedure.

As can be appreciated, securement of any of the components of thepresently disclosed devices can be effectuated using known fasteningtechniques such welding, crimping, gluing, etc.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, the length of the linear rowof staples or fasteners may be modified to meet the requirements of aparticular surgical procedure. Thus, the length of the linear row ofstaples and/or fasteners within a staple cartridge assembly may bevaried accordingly. Therefore, the above description should not beconstrued as limiting, but merely as exemplifications of variousembodiments. Those skilled in the art will envision other modificationswithin the scope and spirit of the claims appended thereto.

What is claimed is:
 1. A shipping wedge for an end effector of anendoscopic surgical device, comprising: an elongate body configured anddimensioned to receive an elongate body portion of an endoscopicsurgical device, the elongate body including a first pair of opposedsidewalls that define a first channel, the first channel extendinglongitudinally through the elongate body; and an angled body thatextends from the elongate body at an acute angle relative to theelongate body, the angled body including a second pair of opposedsidewalls that define a second channel configured and dimensioned tosupport an end effector for connection to the elongate body portion ofthe endoscopic surgical device.
 2. The shipping wedge of claim 1,further including an alignment rib that extends from the first pair ofsidewalls of elongate body, the alignment rib positioned adjacent to theangled body.
 3. The shipping wedge of claim 2, wherein the alignment ribdefines a passage that extends through the alignment rib.
 4. Theshipping wedge of claim 1, wherein the angled body includes aprotuberance that extends from an inner surface of the angled body. 5.The shipping wedge of claim 1, further comprising alignment flanges thatextend from at least one of the first and second pairs of sidewalls. 6.The shipping wedge of claim 1, wherein the angled body prevents the endeffector from moving when the end effector is supported within thesecond channel and positioned in axial alignment with the channel. 7.The shipping wedge of claim 6, wherein the first channel enables the endeffector to move through the first channel when the end effector ispositioned in axial alignment with the first channel.
 8. The shippingwedge of claim 1, wherein at least one of the first and second channelsis U-shaped.
 9. A method of removing an end effector for use with anendoscopic surgical device from a shipping wedge, the method comprising:securing the end effector to the shipping wedge; positioning an elongatebody portion of the endoscopic surgical device within the shippingwedge; advancing the elongate body portion into engagement with the endeffector; pivoting the end effector within the shipping wedge relativeto the elongate body portion; securing the end effector to the elongatebody portion ; and removing the end effector and the elongate bodyportion from the shipping wedge.
 10. The method of claim 9, furtherincluding aligning a distal end of the elongate body portion with aproximal end of the end effector.
 11. The method of claim 10, whereinaligning the elongate body portion includes abutting the elongate bodyportion into engagement with an alignment rib that extends from theshipping wedge.
 12. The method of claim 11, wherein removing the endeffector and the elongate body portion includes passing the end effectorbeneath the alignment rib.
 13. The method of claim 9, wherein securingthe end effector to the shipping wedge includes securing the endeffector to a protuberance that extends from the shipping wedge toprevent the end effector from rotating.
 14. The method of claim 9,wherein securing the end effector to the elongate body portion includesdrawing the end effector into engagement with the elongate body portion.